Urinary incontinence affects over 13 million men and women in the United States. Stress urinary incontinence (SUI) affects primarily women and is generally caused by two conditions, intrinsic sphincter deficiency (ISD) and hypermobility. These conditions may occur independently or in combination. In ISD, the urinary sphincter valve, located within the urethra, fails to close properly (coapt), causing urine to leak out of the urethra during stressful activity. Hypermobility is a condition in which the pelvic floor is distended, weakened, or damaged, causing the bladder neck and proximal urethra to rotate and descend in response to increases in intra-abdominal pressure (e.g., due to sneezing, coughing, straining, etc.). The result is that there is an insufficient response time to promote urethral closure and, consequently, urine leakage and/or flow results. Moreover, the condition of stress urinary incontinence is often compounded by the presence of untreated vaginal vault prolapse or other more serious pelvic floor disorders. Often, treatments of stress incontinence are made without treating the pelvic floor disorders, potentially leading to an early recurrence of the pelvic floor disorder.
These and related conditions, are often treated using an implantable supportive sling. Such slings may be made from a variety of materials, but are often made from a mesh material. The mesh may be placed, for example, under the urethra, close to the high-pressure zone with little or no elevation to the urethra. When abdominal pressure increases, such as from coughing, sneezing, or the like, the sling facilitates the collapse of the urethra as a mechanism for closing the urethra to inhibit urine leakage.
Subsequent to implantation, scar tissue typically forms around the sling. This scar tissue further supports the urethra and sphincter muscle to facilitate complete urethral closure. Clinically, there are two major challenges to a successful outcome—the formation of prominent and permanent scar tissue around the sling, and release of the sling tension to accommodate the body growth. There is a need for an improved surgically implantable sling that better addresses these two challenges.